One of medical technology's leading innovators will kick off this year's event with insights on how our industry is addressing the new health care landscape, and to share ideas on how we can all improve patient care and outcomes.

As MDUFA negotiations continue to progress and other regulatory reforms are being debated, hear from the Director of CDRH on how the agency envisions the next generation of policies to spur innovation. This interactive session will allow attendees to share their suggestions and concerns as well, and provides a unique opportunity to engage with policy makers.

Jeffrey Shuren, MD, Director, CDRH, FDA

9:15am - 9:35am -Early Feasibility Success Story

Hear from Dr. Luis Angel and Carla Wiese, Policy Analyst in the Clinical Trials program focusing on Early Feasibility Studies, CDRH/FDA, as they describe the Angel Catheter, which is the first device to reach U.S. market approval that was evaluated in an Early Feasibility Study in the U.S. as part of this new FDA program. Inventor and Chief Medical Officer, Dr. Luis Angel will describe the road to approval including the challenges that were seen, the benefits that were realized and the lessons learned.

Luis Angel, MD, Chief Medical Officer, BiO2 Medical, Inc.

Carla Wiese, Policy Analyst in the Clinical Trials Program focusing on Early Feasibility Studies, CDRH/ODE/IDE, FDA

9:35am - 10:15am - Industry Response

Leading voices in the industry will respond to FDA's comments, and share their views on what it will take in the regulatory field to improve America's leadership role as we develop the cures and therapies of tomorrow.

While there have been improvements in the med tech ecosystem, challenges remain as innovative companies seek to raise capital to bring their products to the marketplace. Hear from some of the leading venture capitalists on the best strategies to seek out funding and what data you should be prepared to demonstrate.

Josh Makower, General Partner, NEA

Marc Galletti, Partner, Longitude Capital

Allan May, Partner, Life Science Angels

Casey McGlynn, Partner, WSGR (moderator)

10:45am - 11:00am - Networking Break

11:00am - 12:00am - Lessons Learned from Top Executives

The ongoing pressures and opportunities in the health care delivery system have led to unprecedented decisions for companies as they grow. Hear from some of the industry's top executives on how they approach this "new normal," and how they work with their teams, board of directors, outside investors and more to thrive in spite of the complexities.

With increasing pressures to reduce costs, payors are creating new metrics and barriers to secure fair and adequate reimbursement. Learn from some of the industry's leading experts about the right data and game plans you will need to help maximize value for your medical technologies.

Public and Private payors continue to experiment with novel payment models, while more and more networks are becoming vertically integrated. Learn how your team can take advantage of these growing trends, and what policy makers and others are working on to address the growing gap between the regulatory and reimbursement processes.

Various government agencies continue to focus on the health care industry for enforcing regulations and adjudicating violations, though recent decisions have highlighted just how quickly the environment can shift. A powerful panel of compliance experts will share what you and your team need to know about these latest developments.

Carolyn Bruguera, Vice President & General Counsel, MDMA

Mark Duval, President & CEO, DuVal & Associates, PA

Howard Root, Chief Executive Officer, Vascular Solutions

3:30pm - 4:15pm - International Market Access

Clinical trials and Reimbursement considerations are becoming a bigger part of International Market Access now that regulatory requirements are becoming increasing harmonized and mutually recognized among global regulator bodies. Learn about this trend from experts looking to penetrate EU Markets starting with Germany. And hear about the Mark Access trends and opportunities in Mexico and South Korea.

Laura Kemp, Clinical Affairs, Consultant, Ekso Bionics

Gabriela Zelaya, Life Sciences Trade Specialist, U.S. Commercial Service

Ed Rozynski, Senior International Advisor, MDMA (moderator)

4:15pm - 4:45pm - Protecting Innovation

Legislative and court decisions over the past year have continued to shape this country's patent and trade secret laws. Learn how those decisions have affected the strength of patent and trade secret rights, and how they affect your ability to protect your intellectual property in a global market.

Sessions and speakers are subject to change without notice. MDMA reserves the right to cancel or reschedule any program, whereupon full registration fees will be refunded or applied to the rescheduled program in accordance with the registrant's preference. In the event of canceled programs, MDMA assumes no responsibility for transportation, hotel, or other expenses incurred by registrants.